510(k) Report

510(k) · Cleared

Cleared

BNF

K021782510(k) TraditionalCleared Aug 26, 200288-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aap Implantate AG · JDS Nail, Fixation, Bone

Cleared on Aug 26, 2002 as substantially equivalent to K010801 (Howmedica Osteonics Corp., 2001) and 10 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1998.

Decided
Aug 26, 2002
Review
88 days
Class
Class II
Product code
JDS
Recalls
None
Predicates
11

Its longest line of descent runs back 2 generations to K982601 (1998). 14 ancestors in all, the oldest K923597 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors2001: 1 other ancestor1998: 4 other ancestors1997: 2 other ancestors1993: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestorK982601 · Osteo IC Retrograde/Antegrade Femoral Nail · Osteonics Corp. · 1998K011622 · Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2 Locking Screws · Howmedica Osteonics Corp. · 200119901992199419961998200020022004
Other ancestors, by generation 1 generation back: 10 other ancestors2 generations back: 2 other ancestors K011622 · Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2 Locking Screws · Howmedica Osteonics Corp. · 2001K982601 · Osteo IC Retrograde/Antegrade Femoral Nail · Osteonics Corp. · 19980
  1. Root · 2 generations backK982601 Osteo IC Retrograde/Antegrade Femoral NailOsteonics Corp. · 1998
  2. 1 generation backK011622 Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade…Howmedica Osteonics Corp. · 2001
  3. This deviceK021782 BNFAap Implantate AG · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K982601Osteo IC Retrograde/Antegrade Femoral NailOsteonics Corp.1998—
−1K011622Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails…Howmedica Osteonics Corp.2001—
0 (this device)K021782BNFAap Implantate AG2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199720
199840
199910
200010
200110
200220
FIG. 1 — Lineage of K021782, 1998–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JDS device

  1. #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K010801T2 Femoral NailHowmedica Osteonics Corp.20012
*K011622Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2…Howmedica Osteonics Corp.2001—
*K014220T2 Femoral Nail SystemHowmedica Osteonics Corp.2002—
*K970733Synthes Titanium Diastal Femoral Nail (TI DFN) System
Summary page 2
…n size, material and intended use to the Howmedica Osteonics Corp. T2 Femoral Nail System (KO10801 / KO1 1622 / KO14220), Synthes Ti Distal Femoral Nail (K970733)' Synthes Proximal Femoral Nail (K970097), Synthes Titanium Unreamed Femoral Nail (K923597)' Smith 8 Nephew Titanium Nail…
Synthes (Usa)19971
*K970097Proximal Femoral Nail (PFN) System
Summary page 2
…the Howmedica Osteonics Corp. T2 Femoral Nail System (KO10801 / KO1 1622 / KO14220), Synthes Ti Distal Femoral Nail (K970733)' Synthes Proximal Femoral Nail (K970097), Synthes Titanium Unreamed Femoral Nail (K923597)' Smith 8 Nephew Titanium Nail System (K981529), Smith 8 Nephew…
Synthes (Usa)1997—
*K923597Synthes Titanium Unreamed Femoral Nail
Summary page 2
…KO10801 / KO1 1622 / KO14220), Synthes Ti Distal Femoral Nail (K970733)' Synthes Proximal Femoral Nail (K970097), Synthes Titanium Unreamed Femoral Nail (K923597)' Smith 8 Nephew Titanium Nail System (K981529), Smith 8 Nephew Intramedullary Nail System (K983942), DePuy ACE AIM Titan…
Synthes (Usa)1993—
*K981529Titanium Intramedullary Nail, Titanium Locking Screw
Summary page 2
…l Femoral Nail (K970733)' Synthes Proximal Femoral Nail (K970097), Synthes Titanium Unreamed Femoral Nail (K923597)' Smith 8 Nephew Titanium Nail System (K981529), Smith 8 Nephew Intramedullary Nail System (K983942), DePuy ACE AIM Titanium Supracondylar Nail (K974781), Biomet Titani…
Smith & Nephew, Inc.19982
*K983942Intramedullary Nail System, Locking Screw, Nail Cap
Summary page 2
…il (K970097), Synthes Titanium Unreamed Femoral Nail (K923597)' Smith 8 Nephew Titanium Nail System (K981529), Smith 8 Nephew Intramedullary Nail System (K983942), DePuy ACE AIM Titanium Supracondylar Nail (K974781), Biomet Titanium Intramedullary Nails (K982953), Biomet Tit…
Smith & Nephew, Inc.1998—
*K974781Depuy Ace Aim (R) Titanium Supracondylar Nail
Summary page 2
…(K923597)' Smith 8 Nephew Titanium Nail System (K981529), Smith 8 Nephew Intramedullary Nail System (K983942), DePuy ACE AIM Titanium Supracondylar Nail (K974781), Biomet Titanium Intramedullary Nails (K982953), Biomet Titanium Retrograde Femoral Nail (KO13923) Comparision o…
Depuy, Inc.1998—
*K982953Titanium Intramedullary Nails-Various Styles
Summary page 2
…(K981529), Smith 8 Nephew Intramedullary Nail System (K983942), DePuy ACE AIM Titanium Supracondylar Nail (K974781), Biomet Titanium Intramedullary Nails (K982953), Biomet Titanium Retrograde Femoral Nail (KO13923) Comparision o f Technological Characteristics: aap BNF is sub…
Biomet, Inc.19984
*K013923Titanium Retrograde Femoral Nail - 13 MM DiameterBiomet Orthopedics, Inc.2002—

Also cleared against K010801: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 5 of the 14 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K010801.

How does its category compare?

All JDS devices

JDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDS

1in 2025

2007: 22008: 12011: 12013: 12015: 12020: 32023: 12024: 32025: 1
2007high 3 (2020) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDS

146in 2024

2020: 106 days median2024: 146 days median
2007high 146 (2024) · low 106 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDS

2in 2025

2009: 32010: 22013: 42017: 12020: 12025: 2
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDS

497in 2025

2007: 1612008: 1692009: 1602010: 702011: 1042012: 1952013: 2842014: 3882015: 3162016: 5062017: 2872018: 3202019: 4902020: 6432021: 6302022: 5892023: 3572024: 4662025: 497
2007high 643 (2020) · low 70 (2010)2025

MAUDE reports naming product code JDS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—0161
20081—0169
20090—3160
20100—270
20111—0104
20120—0195
20131—4284
20140—0388
20151—0316
20160—0506
20170—1287
20180—0320
20190—0490
202031061643
20210—0630
20220—0589
20231—0357
202431460466
20251—2497
20260—0—

What is it indicated for?

Types of Fractures:

Simple Closed Fractures

Comminuted Fractures

Open Fractures of First, Second or Third Degree

Crush Fractures

Antegrade Indications:

Femur Shaft Fractures

Distal Femur Shaft Fractures

Pathological Fractures (e.g. Tumor Osteolysis)

Periprosthetic Femur Fracture in the Middle of Third Part with Knee Replacement in Situ

Retrograde Indications:

Supracondylary Fractures

Simultaneous Nailing of Femur and Tibia

Distal Femur Fracture with Osteosynthesis or Hip Prosthesis in Situ

Periprosthetic Femur Fracture at Knee Arthosplasty

Borderline Indications: Percondylar Femur Fracture,

Indications for use as stated in the FDA summary.

Also cleared against K010801

11 other devices cite the same predicate.

  • K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2…Stryker GmbH · 2020
  • K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden…Truemed Group, LLC · 2018
  • K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A · 2014
  • K112059T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker · 2011
  • K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 20111 recall
  • K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 20111 recall

More from Aap Implantate AG

37 FDA decisions under this applicant name. See the company

  • K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG · 2026
  • K233008Cannulated Headless Bone ScrewsAap Implantate AG · 2024
  • K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG · 2023
  • K211582LOQTEQ Proximal Humerus Plate 3.5 SystemAap Implantate AG · 2021
  • K210043LOQTEQ Distal Lateral Femur Plate 4.5 SystemAap Implantate AG · 2021

Recent decisions in JDS

The JDS category page

  • K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
  • K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc. · 2024
  • K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc. · 2024
  • K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd. · 2024
  • K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. · 2023

https://510kreport.com/device/K021782 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021782: BNF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021782

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026